Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.This guidance indicates that the FDA views risk management as an iterative process encompassing the assessment ... Annotated QRD Product Information template for Centralised Procedure, EMEA. http:// www.emea.europa.eu/htms/ human/qrd/docs/Hannotatedtemplate.pdf (Accessed ... A guideline on the readability of the label and package leaflet of medicinal products for human use, Pharmaceuticalanbsp;...
|Title||:||International Pharmaceutical Product Registration, Second Edition|
|Author||:||Anthony C. Cartwright, Brian R. Matthews|
|Publisher||:||CRC Press - 2009-08-26|